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Referencing FDA's MedWatch Program
The following represents current information on reporting mechanisms that should be used when
referring to FDA's MedWatch Program.
Adverse events, product quality problems and/or product use errors can be reported to FDA's MedWatch Adverse
Event Reporting program:
Examples of how such information could be incorporated in Dear Healthcare Professional letters:
Healthcare professionals are strongly encouraged to submit a report of any serious adverse events that
occur with the use of 'Product X' to 1-800-xxx-xxxx or to the FDA's MedWatch Adverse Event Reporting program
online [at www.fda.gov/MedWatch/report.htm ], by
phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm]
by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178]. |
-- or --
Adverse events with "Product X' can be reported to 'XXXX' Pharmaceuticals by phone (888) xxx-xxxx
or the Internet at www.xxxx.com .
Alternatively, this information may be reported to the FDA's MedWatch Adverse Event Reporting program
online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178]. |
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